Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
W.L.Gore & Associates
The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.
Age
Any age
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
ASD less than or equal to 18 mm.
You may not be if
Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
